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Composition for dronedarone hydrochloride tablet and preparation method thereof

A dronedarone hydrochloride tablet and a technology for preparing dronedarone hydrochloride are applied in the field of dronedarone hydrochloride tablet composition and preparation thereof, and can solve the absorption effects of dronedarone hydrochloride, complicated process, low dissolution performance, etc. problems, to achieve the effect of a wide range of applicable people, high bioavailability and complete absorption

Inactive Publication Date: 2015-06-24
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the prior art has improved the solubility of dronedarone hydrochloride to a certain extent, there are still defects such as complex process and low dissolution performance.
For example, the dissolution rate of the dronedarone hydrochloride tablet prepared by CN103565763A in the phosphate buffered saline solution of pH 4.5 can reach more than 97%, but the highest dissolution rate in the phosphate buffered saline solution of pH 6.8 can only reach 48% , those skilled in the art can predict that this will have a serious impact on the absorption of dronedarone hydrochloride in the intestinal tract

Method used

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  • Composition for dronedarone hydrochloride tablet and preparation method thereof
  • Composition for dronedarone hydrochloride tablet and preparation method thereof
  • Composition for dronedarone hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 Dronedarone hydrochloride tablet (400mg / tablet) of the present invention

[0024] prescription:

[0025]

[0026] Preparation Process:

[0027] Dissolve the prescribed amount of sodium lauryl sulfate and polyethylene glycol in water, add dronedarone hydrochloride to make soft materials, granulate, dry, and granulate, add pregelatinized starch, microcrystalline cellulose, cross-linked polymer Vitamin ketone and magnesium stearate are mixed evenly and pressed into tablets to obtain the product.

Embodiment 2

[0028] Embodiment 2 Dronedarone hydrochloride tablet (400mg / tablet) of the present invention

[0029] prescription:

[0030]

[0031] Preparation Process:

[0032] Dissolve the prescribed amount of sodium lauryl sulfate and polyethylene glycol in water, add dronedarone hydrochloride to make soft materials, granulate, dry, and granulate, add pregelatinized starch, microcrystalline cellulose, cross-linked polymer Vitamin ketone and magnesium stearate are mixed evenly and pressed into tablets to obtain the product.

Embodiment 3

[0033] Example 3 Dronedarone Hydrochloride Tablets (800mg / tablet) of the present invention

[0034] prescription:

[0035]

[0036] Preparation Process:

[0037] Dissolve the prescribed amount of sodium lauryl sulfate and polyethylene glycol in water, add dronedarone hydrochloride to make soft materials, granulate, dry, and granulate, add pregelatinized starch, microcrystalline cellulose, cross-linked polymer Vitamin ketone and magnesium stearate are mixed evenly and pressed into tablets to obtain the product.

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PUM

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Abstract

The invention provides a composition for a dronedarone hydrochloride tablet and a preparation method thereof. The dronedarone hydrochloride tablet is prepared from an active component, a surfactant, lauryl sodium sulfate and other pharmaceutically acceptable components, wherein the active component is dronedarone hydrochloride, and the surfactant is polyethylene glycol. The dronedarone hydrochloride tablet has high dissolution rate and is suitable for industrial production, and the preparation process of the dronedarone hydrochloride tablet is simple.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dronedarone hydrochloride tablet composition and a preparation method thereof. Background technique [0002] Dronedarone hydrochloride (Dronedarone hydrochloride) is an antiarrhythmic drug developed by Sanofi-Aventis in France. Its structure is similar to that of the typical antiarrhythmic drug amiodarone. For the treatment of paroxysmal or persistent atrial fibrillation. The chemical name of dronedarone hydrochloride is N-{2-butyl-3-[4-(3-dibutylaminopropanol)benzoyl]benzofuran-5-yl}methylsulfonamide hydrochloride Salt, relative molecular weight 593.2, structural formula as follows: [0003] [0004] Dronedarone hydrochloride is safe and can effectively treat atrial fibrillation, but it has poor solubility and is insoluble in water. The concentration of dronedarone hydrochloride is about 1-2mg / ml in buffer solution within the range of pH3-5, and only 10μg / ml at...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K9/20A61K47/34A61K47/20A61K47/38A61P9/06
Inventor 刘淑景
Owner HEBEI RENHE YIKANG PHARMA
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